RECRUITING

Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant

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Conditions

Hematologic MalignanciesAllogeneic Transplantation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this phase 1 study is to determine the optimal dose of the immune suppressive drug, cyclophosphamide, following standard allogeneic stem cell transplant in patients aged \>/= 65 years with hematologic malignancies.

Official Title

IIT2022-03-Paquette-GeriBMT: A Phase I Study of De-Escalation of Post-Transplant Cyclophosphamide Dosing in Patients Aged >/= 65 Years Undergoing Conditioning With Fludarabine and Total Body Irradiation 800 cGy

Quick Facts

Study Start:2023-10-24
Study Completion:2028-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05849207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient age \>/= 65 years
  2. * Patient has a related donor who is a human leukocyte antigens (HLA) haploidentical match
  3. * Patient and Donor sign the Informed Consent Form for the study
  4. * Patient meets standard criteria for allogeneic stem cell transplant
  5. * Patient is deemed suitable to receive Flu/TBI 800 conditioning regimen as standard of care transplant
  6. * Donor is willing to donate peripheral blood stem cells (PBSC)
  1. * Patient has a diagnosis of myelofibrosis
  2. * Patient has high titer antibodies (\>10,000 mean fluorescent intensity) against one or more donor HLA antigens
  3. * Patient has undergone prior autologous or allogeneic stem cell transplant
  4. * Inability to collect at least 3 x 10\^6 CD34+ PBSCs/kg recipient weight from the donor
  5. * Requiring sedation for cardiac MRIs.
  6. * Prohibited Implants and/or Devices:
  7. * Mechanical, magnetic or electrical activated implants (i.e. cardiac pacemakers, neurostimulators and infusion pumps)
  8. * Ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
  9. * Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.

Contacts and Locations

Study Contact

Amy Oppenheim
CONTACT
310-423-3713
Amy.Oppenheim@cshs.org
Nadia Nassaj
CONTACT
310-423-7735
mehrnoosh.nassaj@cshs.org

Principal Investigator

Ronald Paquette, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Ronald Paquette

  • Ronald Paquette, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-24
Study Completion Date2028-07-01

Study Record Updates

Study Start Date2023-10-24
Study Completion Date2028-07-01

Terms related to this study

Keywords Provided by Researchers

  • Allogeneic Transplantation

Additional Relevant MeSH Terms

  • Hematologic Malignancies